MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ UNIVERSAL ELECTROSURGICAL PADS; GROUNDING PAD

Model Number 9160F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 02/28/2022

Event Type  Injury  

Event Description

A male pediatric patient experienced an 8cm x 2cm transverse lesion on that anterior aspect of the left thigh with the use of 3m¿ universal electrosurgical pads 9160f, lot 20250er.A second-degree burn, necrotic tissue, small blisters, erythema, itching/burning sensation and signs of retraction with a small halo of hyperemia were observed.After two days, the burn was re-assessed and was subsequently deemed a post operative 9cm x 2.5cm third-degree burn with ruptured blisters and devitalized tissue allegedly caused by the 3m¿ universal electrosurgical pads 9160f.The wound was reportedly drier with little exudate and no phlogistic signs were observed.A nurse reported that medical treatment was necessary.The wound was cleaned with saline solution, without sharp debridement, and silver sulfadiazine with duoderm® cgf¿ dressing® was applied for autolytic debridement.Subsequent reassessment reported cleaned dead skin (bleeding) and duoderm® cgf¿ dressing® was applied to keep necrosis adhered to the wound bed.The next dressing change schedule was extended one day to reportedly promote autolytic debridement.No permanent injury was reportedly confirmed.The patient is reportedly doing well and is undergoing follow up in the hospital's outpatient facility where the wound team are using hydrogel with duoderm® hydroactive® gel.

Manufacturer Narrative

Product sample was not returned to 3m for analysis; however, review of manufacturing records/retains confirmed that released lot met all specification.Without additional information, it is not possible to determine the root cause of the alleged injury or whether a 3m¿ universal electrosurgical pad was the root cause.To reduce the risk of burns, all instructions should be followed as per the instructions for use (ifu).The instructions for use states, to reduce the risk of burns the site must be clean, dry and free of hair and to remove hair at application site.3m¿ will continue to monitor.

• Brand Name: 3M¿ UNIVERSAL ELECTROSURGICAL PADS
• Type of Device: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 meigs st.; valley NE 68064
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15633835
• MDR Text Key: 302022093
• Report Number: 2110898-2022-00109
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10707387462618
• UDI-Public: 10707387462618
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K974553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9160F
• Device Catalogue Number: 9160F
• Device Lot Number: 202504EP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 14 KG
• Patient Ethnicity: Hispanic